Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair

NCT02044003 | Completed DMC

• 1 other identifier: 2009-A
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.

Conditions

Critical Limb Ischemia; Peripheral Artery Disease

Keywords

angioplasty; dissections

Outcome Measures

Primary Outcomes (1)

• Evaluation of Safety

  Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.

  30 days

Secondary Outcomes (1)

• Evaluation of Feasibility

  Conclusion of implant procedure

Other Outcomes (2)

• Evaluation of post-implant stability

  30 and 90 days

• Patency

  30 and 90 days

Study Arms (1)

Post Angioplasty Dissection Repair

EXPERIMENTAL

Implant of Innovasc Tack Intravascular Staple System (Tack) to repair post angioplasty dissections

Device: Innovasc Tack Intravascular Staple System (Tack)

Interventions

Innovasc Tack Intravascular Staple System (Tack) DEVICE

Tack-It Dissection repair

Also known as: Intact Vascular Tack-It, Tack-It Endovascular Dissection Repair System

Post Angioplasty Dissection Repair

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 and \< 85 years
• Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
• Patient has documented chronic limb ischemia with Rutherford Category 2, 3, 4, or 5. Clinical conditions of claudication or rest pain or ischemic ulceration or minor gangrene as diagnosed by the investigator
• Reference vessel diameter between 2 and 7mm
• Target lesion is not severely calcified
• At least one patent tibial runoff vessel is present.
• Patient has patent iliac or femoral arteries that allow endovascular access to the site with the Introducer Sheath or Delivery Catheter or these can be treated at the time of the procedure and achieve a \<30% residual stenosis at each inflow lesion.
• Ability to pass the guidewire across the atherosclerotic lesion.
• No evidence of aneurysm or acute thrombus in target vessel.

You may not qualify if:

• Severe or infected gangrene of the lower extremity
• Planned major amputation
• Previously implanted stent at the treatment site
• Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization.
• Patient has connective tissue disease (e.g., Marfan's syndrome).
• Inability to tolerate antiplatelet agents
• Patient is hypercoagulable
• Patient has allergy to vascular contrast for which they cannot be premedicated.
• Patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of \>2.2 mg/dL.
• Patient has active systemic infection
• Patient has a less than one year life expectancy.
• Patient is pregnant or nursing.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (2)

Italian Hospital (Final treatment hospital and all follow-up)

Asunción, Paraguay

Location

Santa Clara Medical Center (initial treatment hospital)

Asunción, Paraguay

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Adrian Ebner, MD

  Santa Clara Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 23, 2014
• Study Start: December 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

PA (2)